From the U.S. Government Accountability Office, www.gao.gov
Transcript for: FDA Oversight of Drug Compounding
Description: Audio interview by GAO staff with Marcia Crosse, Director,
Health Care
Related GAO Work: GAO Work: GAO-13-702: Drug Compounding: Clear Authority
and More Reliable Data Needed to Strengthen FDA Oversight
Released: July 2013
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[ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and
information from the U.S. Government Accountability Office. It's July,
2013. A pharmacist can compound drugs, combine, mix, or otherwise alter
them to meet a customer's medical needs. In 2012, contaminants in
compounded drugs let to an outbreak of fungal meningitis. A team led by
Marcia Crosse, a director in GAO's Healthcare team, recently examined
the federal government's role in overseeing drug compounding. GAO's
Sarah Kaczmarek sat down with Marcia to talk about what they found.
[ Sarah Kaczmarek: ] How would you describe the federal government's
role in insuring the safety of drug compounding?
[ Marcia Crosse: ] Well I think the federal government's role has been a
little unclear. The oversight of pharmacies has traditionally been a
responsibility for states and there had been some concern that
pharmacies, or at least some pharmacies, were starting to produce drugs
in large quantity. These compounded drugs where pharmacists actually
mixes up a medication, and they weren't just doing it in larger
quantities, they were also beginning to ship it interstate between
different locations, and interstate commerce has normally been the
responsibility of the federal government, so Congress enacted some
legislation, but the courts have ruled differently on that. The federal
responsibility has been a little muddled.
[ Sarah Kaczmarek: ] Okay. So with that then, what's FDA doing now to
oversee drug compounding?
[ Marcia Crosse: ] Well, given the problems that occurred last year with
the outbreak of meningitis from contaminated compounded drugs, FDA has
stepped up its oversight and particularly for these larger compounders
that have been producing sterile medications--injectable
medications--where there's a high risk if the product is contaminated.
FDA has begun to go in and do inspections in these facilities and try to
point out problems, and this has actually resulted in a number of
recalls of medications from a lot of different drug compounding
pharmacies. However, there's still some question about what authority
FDA has to oversee these pharmacies, and how long they can sustain this
higher level of review.
[ Sarah Kaczmarek: ] Now you mentioned that states have a role here. So
what are states and pharmacy organizations doing to provide oversight as
well?
[ Marcia Crosse: ] Yes, states have also increased their oversight of
pharmacies. They've been doing additional inspections and trying to get
more information about the pharmacies that are located in their states.
And some states have actually contracted with National Pharmacy
Organization to do some inspections of pharmacies that are located in
other states, and to provide them with additional information about the
pharmacies that may be shipping drugs into their state. Because a state
really only has oversight of the pharmacies that are located within
their borders, and they need to understand the full picture of which
pharmacies are shipping drugs to their state.
[ Sarah Kaczmarek: ] And GAO is making recommendations to help insure
appropriate oversight. Could you talk about those?
[ Marcia Crosse: ] Yes, we are recommending that Congress should
consider clarifying FDA's responsibility. As I said, the courts have had
different rulings so that the rules in operation in different parts of
the country have varied because different courts have made different
rulings. We think that should be clarified and exactly where FDA's
responsibility starts and ends should be cleared up. Right now, there
seems to be some consensus that if you're making a medication--a
pharmacist is making a medication for one patient with a prescription
from a pharmacist, that's fine. That doesn't require FDA's oversight. If
a pharmacy may be making, you know a dozen or 25 doses because they know
they regularly get that many orders in a week or in a month that may be
okay. What's not clear is where you cross the boundary from doing
normal, traditional drug compounding into drug manufacturing. And when
you're doing drug manufacturing, that's where FDA has had the
responsibility, and we don't want to have a situation where drug
manufacturers making thousands of doses that they ship interstate elude
oversight and inspection responsibility from FDA by calling themselves
compounders.
[ Sarah Kaczmarek: ] So finally for consumers concerned about
pharmaceutical drug safety, what's the bottom line here?
[ Marcia Crosse: ] Most individuals are getting medications that are
under regular drug manufacturing rules. When you go and you get a bottle
of pills from a pharmacy, that's not the kind of drug we're talking
about. A compounded drug is something that's made up especially for an
individual patient, either because they may have some sensitivity to the
ingredients or because they need a different form. They may need a
liquid form of a medication, and normally it only comes in pills. Or for
some kinds of hospital procedures or other source of medical procedures,
they may need to have special drugs combined, things mixed, and that's
where you get into compounding. So I think that if you're talking about
something other than your sort of routine medications that you're
obtaining all the time, you just want to ask some questions of your
provider and of your pharmacy to understand what it is you're being
given.
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